Flexible Drill Shaft recall
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Why was Flexible Drill Shaft recalled?
Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 262667L01
- Product
- Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
- Recalling firm
- Encore Medical, Lp
- Quantity
- 21
- Distribution
- US ( MS, NY, MO, OK, UT, AZ)
- Recall date
- August 7, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)